Device, a system and a method for identification/authentication of parts of a medical device

ABSTRACT

Disclosed is a dispensing system. The dispensing system includes a dispensing unit to dispense therapeutic fluid, and a validation mechanism to enable operation of the dispensing unit based, at least in part, on a determination of whether operation of the dispensing device is authorized.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/995,068, now U.S. Pat. No. 9,138,531, filed Jan. 26, 2011, which is aU.S. National Phase Entry of International Patent Application No.PCT/IL2009/000533, filed May 27, 2009, which claims the benefit to U.S.Provisional Application Ser. No. 61/057,088, filed May 29, 2008, all ofwhich are herein incorporated fully by reference.

TECHNICAL FIELD

The present disclosure relates generally to a system, a method and adevice for sustained infusion of fluids. More particularly, the presentdisclosure relates to a portable infusion device comprising at least twoparts and a method for the parts identification/authentication beforeand/or during the device is assembled from the parts. More particularly,the present disclosure relates to a skin securable dispensing patchcomprising a reusable part, a disposable part and a cradle unit, and toa method for parts authentication/identification.

BACKGROUND

Diabetes mellitus is a disease of major global importance, increasing infrequency at almost epidemic rates, such that the worldwide prevalencein 2006 is 170 million people and predicted to at least double over thenext 10-15 years. Diabetes is characterized by a chronically raisedblood glucose concentration (hyperglycemia), due to a relative orabsolute lack of the pancreatic hormone, insulin.

Treatment of diabetes mellitus requires frequent insulin administrationthat can be done by multiple daily injections (MDI) with syringe or bycontinuous subcutaneous insulin injection (CSII) with insulin pumps. Inrecent years, ambulatory portable insulin infusion pumps have emerged asa superior alternative to multiple daily injections of insulin. Thesepumps, which deliver insulin at a continuous basal rate as well as inbolus volumes, were developed to liberate patients from repeatedself-administered injections, and allow greater flexibility in doseadministration.

Several ambulatory insulin infusion devices are currently available onthe market. Examples of first generation disposable syringe-typereservoir and tubes were disclosed in U.S. Pat. No. 3,631,847 to Hobbs,U.S. Pat. No. 3,771,694 to Kaminski, U.S. Pat. No. 4,657,486 toStempfle, and U.S. Pat. No. 4,544,369 to Skakoon. Other dispensingmechanisms have also been discussed, including peristaltic positivedisplacement pumps, in U.S. Pat. No. 4,498,843 to Schneider and U.S.Pat. No. 4,715,786 to Wolff, the contents of all of which are herebyincorporated by reference in their entireties.

Although these devices represent an improvement over multiple dailyinjections, they nevertheless all suffer from several drawbacks,including, for example, their large size and weight, caused by theirconfiguration and the relatively large size of the driving mechanismsand of the syringes. These relatively bulky devices have to be carriedin a patient's pocket or be attached to the belt. Consequently, thefluid delivery tubes of the infusion set are very long, usually longerthan 60 cm, in order to permit needle insertion at remote sites of thebody. These uncomfortable bulky devices and long infusion set arerejected by the majority of diabetic insulin users since they disturbregular activities such as sleeping and swimming. Furthermore, theeffect of the image projected on the teenagers' body is unacceptable. Inaddition, the delivery tube excludes some optional remote insertionsites, like buttocks, arms and legs.

To avoid the consequences of long infusion sets, a new concept, referredto as a second generation pump, was proposed. This concept includes aremote controlled skin adherable device with a housing having a bottomsurface adapted to contact patient's skin, a reservoir disposed withinthe housing, and an injection needle adapted to communicate with thereservoir. These skin adherable devices are disposed every 2-3 dayssimilarly to available pump infusion sets. These devices were described,for example, in at least in U.S. Pat. No. 5,957,895 to Sage, U.S. Pat.No. 6,589,229 to Connelly, and U.S. Pat. No. 6,740,059 to Flaherty.Additional configurations of skin adherable pumps were described, forexample, in U.S. Pat. No. 6,723,072 to Flaherty and U.S. Pat. No.6,485,461 to Mason, the contents of all of which are hereby incorporatedby reference in their entireties. These devices also have severallimitations: they are also bulky and expensive. Their high selling priceis due to the high production and accessory costs; the user must discardthe entire device every 2-3 days, including the relatively expensivecomponents, such as driving mechanism and electronics.

A third generation dispensing device, such as the Medingo devicedescribed in co-pending/co-owned U.S. publication no. 2007-0106218 andInternational Patent Application No. PCT/IL06/001276, the contents ofall of which are hereby incorporated by reference in their entireties,is a miniature portable programmable fluid dispenser that has no tubingand can be attached to the patient skin. It includes of two parts, adisposable part (DP) and a reusable part (RP). After connection of thereusable and the disposable parts, the unified dispensing unit presentsa thin profile. The RP contains electronics and other relativelyexpensive components and the DP contains reservoir. The Medingo deviceincludes a remote control unit that enables data acquisition,programming, and user inputs. An improvement to a skin adherable pumpthat includes of the two parts is described in co-pending/co-owned U.S.publication no. 2008-0215035 and International Patent Application No.PCT/IL09/000,388, the contents of all of which are hereby incorporatedby reference in their entireties. In this application, a device, asystem and a method for connection and disconnection of a skin securablepump is disclosed. The system enables the use of a cradle, which isinitially adhered to the skin and then a cannula is inserted through thecradle into the body of the user. The cannula, which is a sterilizedcomponent, is provided to the patient protected in a cannula cartridgeunit. An example for such cannula cartridge unit including a cannula isdescribed in co-pending/co-owned U.S. publication 2008-0319416, thecontent of which is hereby incorporated by reference. The two-part pumpcan be consequently connected and disconnected to and from the cradleupon patient discretion. The cannula, cradle, and disposable part areall designed for a single use and are preferably sterilized, to preventcontaminations, irritations, infections and other ill effects. And thus,they should be replaced every several days (e.g. once or twice a week).

Such a device, as described in the above-mentioned patents assigned toMedingo, comprises a number of parts, some of which are disposable.These parts require authentication and identification before and/orduring assembling the parts for the following reasons:

1. Intentional or inadvertent reuse of any of the parts might havehazardous consequences on the user. For example, reuse of a cannula maylead to a local, and even systemic infection, reuse of a reservoir maylead to a deficiency of insulin which might result in hyperglycemia.Identification and authentication would allow tracking of the differentparts and thus prevent their intentional or inadvertent reuse. Trackingcan be done for example, by storing the serial number of the assembleddisposable parts in the memory and preventing assembling from disposableparts with the same serial number.2. As part of the quality control of the genuine device, inspections andtests are carried out, and all components and materials must conform topre-defined specifications. Use of imitations instead of genuine partsmight have hazardous consequences on the user because the imitations donot undergo strict quality control and therefore do not conform to thehigh standards that the genuine parts must meet. For example, use ofimitation parts that do not meet the sterility standards may lead toinfections. Authentication of the different parts during assembly of theparts may therefore prevent the use of imitations.3. Use of parts whose expiry date has elapsed might have hazardousconsequences on the user, for example, the consequence of using insulinafter expiry date is deleterious. Determination of the expiry date ofthe different parts during their assembly may thus prevent the use ofparts whose expiry date has passed.4. Assembling of device from parts belonging to different users mightalso have hazardous consequences on the user. For example, the DPs ofdifferent users may comprise different reservoir volumes or differenttherapeutic agents (e.g. insulin 100 U/mL or 40 U/mL), and faultyassembly may therefore result in fatal consequence due to underdosing oroverdosing. Parts identification may prevent assembling of device fromRPs and DPs belonging to different users.

Parts identification and/or validation could therefore preventintentional or inadvertent reuse of any of the parts.

SUMMARY

Some embodiments of the present disclosure describe a portable devicecomprising multiple parts, from which the device is assembled. Thedevice, upon assembly, delivers therapeutic fluid (e.g., insulin) intothe body and implements a method for identification and authentication(i.e. validation) of the different parts of the device before and/orduring device assembly.

In some embodiments the device comprises, a processor, controlling thedriving mechanism according to at least some of the data received from auser, an identification means (e.g. ID marker) for authenticating aportion (e.g. part, component) of the system, an identification readingmeans (e.g. ID reader) for reading the identification means and forproviding a signal to the processor.

According to some embodiments the device further comprises a cradle unitconfigured to secure a dispensing unit onto the body of the user,includes the ID marker, which provides indication to an ID reader.

In some embodiments the identification means is associated with acannula. The cannula is insertable into the body of the user, providinga fluid path between a reservoir containing the therapeutic fluid andthe user's body.

In some embodiments the identification means is associated with areservoir. The reservoir is configured to contain a therapeutic fluid.

In some embodiments the identification reading means is located in adispensing unit. According to some embodiments the dispensing of thetherapeutic fluid may be enabled and/or disabled based on the validationof the identification means.

In some embodiments the identification reading means is located in aremote control unit. The remote control unit may communicate with thepatch unit and may be enable its programming, user input, and/or dataacquisition.

In some embodiments the identification reading means is located in aninserter, configured to insert a cannula into the body of a user.According to some embodiments the insertion of the cannula can beenabled and/or disabled based on the validation of the identificationmeans.

The system according to some embodiments of the present disclosurecomprises a dispensing patch unit (also referred-to as a “patch unit”and/or “dispensing unit”) and, in some embodiments, may be part of asystem which includes a remote control unit, a cradle unit and a cannulacartridge unit.

Some embodiments of the present disclosure describe a system comprisingmultiple parts. The system is configured to enable the programming oftherapeutic fluid (e.g., insulin) delivery into the body and to deliverthe therapeutic fluid. The system implements a method for identificationand authentication (i.e. validation) of the different parts of thesystem.

In some embodiments the system comprises a reservoir to contain atherapeutic fluid (e.g. insulin), a cannula insertable into a body of auser, enabling fluid communication between the reservoir and the user'sbody, a driving mechanism including a motor and at least one gear,configured to engage with the reservoir to dispense the therapeuticfluid, a user interface configured to receive data from the user and tonotify the user, at least one processor, controlling the drivingmechanism according to at least some of the data received from the user,an identification means (e.g. ID marker) for authenticating at least aportion of the system, an identification reading means (e.g. ID reader)for reading the identification means and for providing a signal to theat least one processor and at least one power source (e.g. battery) toprovide power to at least one of the driving mechanism, theidentification means, the at least one processor and the user interface.

According to some embodiments, the processor can change the status ofthe system to enable/disable at least one function of the system basedon the signal received from the identification reading means.

In some embodiments the identification means comprises an identificationtag storing the identification information, and the identificationreading means comprises an identification reader to read theidentification information stored on the identification tag.

In some embodiments the identification means includes an RFIDtransponder and the identification reading means comprises an RFIDantenna.

In some embodiments the identification means includes a digital memorystoring the identification information and the identification readingmeans comprises a digital memory reader.

In some embodiments the identification means includes a bar coderepresentative of the identification information, and the identificationreading means comprises a bar code reader.

In some embodiments, authentication includes establishing or confirminga product or a part is genuine.

The system according to some embodiments of the present disclosurecomprises a dispensing patch unit and, in some embodiments, may be partof a system which includes a remote control unit, a cradle unit and acannula cartridge unit. The remote control unit may communicate with thepatch unit and may enable its programming, user input, and/or dataacquisition. The cradle unit according to some embodiments may beconfigured as a substantially flat plate that adheres to the skin andenables patch disconnection and reconnection upon patient discretion.Some embodiments of the cannula cartridge unit include a cannula that isinsertable through a passageway in the cradle unit. In some embodiments,the system further comprises an inserter to insert the cannula into abody of a user.

Identification and authentication can be possible for one or more partsof the system. In some embodiments, the patch unit is composed of twoparts—a disposable part which will be referred-to as DP and a reusablepart which will be referred-to as RP. Parts authentication may beachieved by providing an identification marker (e.g. RFID identificationtag) at the DP and an identification reader at the RP.

In some embodiments, an identification tag can be deployed in and/or onthe cradle unit and an identification reader provided for with the patchunit allowing identification and authentication during the patchdisconnection and reconnection, for example. That is, the patch unit mayidentify the cradle unit each time they are reconnected, and thus, forexample, reconnection of patch units belonging to different users isprevented. Furthermore, in some embodiments, delivering therapeuticfluid (e.g. insulin) into a body of a patient may depend on theidentification and/or authentication during patch disconnection andreconnection. For example, therapeutic fluid delivery may be suspendedwhen there is no identification reading and resumed when there is anidentification reading. Additionally and/or alternatively, the operationof the patch unit may be altered based on the identification reading toenable usage in emergency situations even if there is no authenticationand/or there is a mismatch of the identification reading (e.g. usingparts from different users).

A therapeutic fluid dispensing system according to some embodiments ofthe present disclosure comprises a patch (i.e., dispensing) unit and aremote control unit. The remote control unit may communicate with thepatch unit and/or enable programming, user input, and/or dataacquisition of the patch unit. Communication between the units (e.g.remote control unit and patch unit) may be identified by at least onespecific key shared by the units (for example). Setting the key sharedby the units may also be referred to as “pairing”. Paired unitscommunicate with each other, but do not communicate with other units.Pairing the units and/or transferring the shared key can be done, forexample, by reading an identification means (e.g. identification tag).

Accordingly, an object of some of the embodiments of the presentdisclosure is to provide a dispensing device (and in some embodiments, asystem) that comprises more than one part and implements a method foridentification and authentication the different parts of thedevice/system before and/or during the assembling of the parts.

Another object of some of the embodiments of the present disclosure isto provide a dispensing device (and in some embodiments, a system),which comprises one or more reusable parts having an identificationreader and one or more disposable parts having an identification tag,and which is configured to perform identification and authentication(whichever the case may be) of the reusable and disposable parts.

Another object of some of the embodiments of the present disclosure isto provide a dispensing device, for example, which comprises one or morereusable parts having an identification FLASH reader and one or moredisposable parts having a FLASH identification tag, and which isconfigured to perform parts identification and authentication employinga Read Write memory FLASH system.

Another object of some of the embodiments of the present disclosure isto provide a mechanical identification marker and a mechanical reader.The mechanicals reader and identifier interact with each other to enablemechanical connection. In some embodiments the identification markerfits to the identification reader as a key to a lock. Additionallyand/or alternatively the connection between the identification markerand the identification enable at least one function of the system,preferably the dispensing of therapeutic fluid to the body of a user.

Another object of some of the embodiments of the present disclosure isto provide a method to identify, authenticate and/or validate componentsof system for dispensing a therapeutic fluid to a body of a user. Themethod may include reading an identification means with theidentification means reader and disabling/enabling at least one functionof the system according to the signal provided from the identificationmeans reader.

Some embodiments of the present disclosure describe a system comprisingmultiple parts. The system is configured to enable the programming oftherapeutic fluid (e.g. insulin) delivery into the body and to deliverthe therapeutic fluid. The system implements a method for identificationand authentication (i.e. validation) of the different parts of thesystem.

Yet another object of some of the embodiments of the present disclosureis to provide a dispensing device, for example, which comprises one ormore reusable parts having an identification antenna, serving as anidentification reader and one or more disposable parts having atransponder, serving as an identification tag, and which is configuredto perform parts identification and authentication employing a RadioFrequency Identification Devices (RFID).

A further object of some of the embodiments of the present disclosure isto provide a dispensing device, for example, which comprises one or morereusable parts having barcode scanner serving as an identificationreader and one or more disposable parts having barcode serving as anidentification tag, and is configured to perform parts identificationand authentication employing a barcode system.

Yet another object of some of the embodiments of the present disclosureis to provide a dispensing device which comprises one or more reusableparts having a miniature mechanical lock as an identification reader andone or more disposable parts having a miniature mechanical key as anidentification tag, and which is configured to perform partsidentification and authentication employing a miniature mechanicalkey-lock system.

It would therefore be desirable to implement parts authentication toavoid imitations and to make sure that genuine parts are used.

It would also be desirable to implement parts identification to verifythat parts expiry date has not lapsed.

Parts identification would also be desirable to prevent assembly of RPsand DPs of different users.

Accordingly, it would be desirable to provide a third generationdispensing device and a method for identification and authentication ofthe different parts, from which it is assembled before and/or duringassembling.

It would also be desirable to provide a device that delivers insulininto the body and can concomitantly continuously monitor glucose in thebody (e.g. contained in blood, ISF) and perform identification andauthentication of the different parts of the device during deviceassembly.

It would further be desirable to provide a device which is miniature,discreet, economical for the users and cost effective, as well as toprovide a method for identification and authentication of the differentparts of the device during device assembly.

It would additionally be desirable to provide a device that includes aminiature dispensing patch unit that can be connected and disconnectedto and from a skin adhered cradle unit upon patient discretion and cancontinuously/periodically dispense insulin and implement a method foridentification and authentication of the different parts of the deviceduring device assembly.

It would also be desirable to provide a device that comprises an insulindispensing patch unit that can be remotely controlled and could performidentification and authentication of the different parts of the deviceduring device assembly.

It would further be desirable to provide a device that comprises aremote control unit than communicates with insulin dispensing patchunit, and could perform identification and authentication of thedifferent parts of the device during device assembly.

It would also be desirable to provide a device that comprises aminiature skin securable dispensing patch that can continuously dispenseinsulin and monitor body glucose concentration levels, and could performidentification and authentication of the different parts of the deviceduring device assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-b are schematic diagrams of an exemplary dispensing devicecomprising a two-part patch unit, as well as a remote control unit,according to some embodiments of the present disclosure.

FIG. 2 is a schematic diagram of an exemplary infusion device thatcomprises a two-part patch unit secured to a skin-adherable cradle unit,as well as a remote control unit, according to some embodiments of thepresent disclosure.

FIG. 3 is a schematic diagram of an exemplary two parts of the patchunit including two opposing identification components according to someembodiments of the present disclosure.

FIG. 4a is a schematic diagram of an exemplary system for dispensing atherapeutic fluid to a patient according to some embodiments of thepresent disclosure.

FIG. 4b is a perspective view of the exemplary system of FIG. 4 a.

FIG. 5 is a flow chart of an exemplary procedure performed with respectto opposing the identification tag and identification reader accordingto some embodiments of the present disclosure.

FIG. 6 is a schematic diagram of an RFID-based system that can be usedto perform identification and authentication for an insulin dispensingdevice according to some embodiments of the present disclosure.

FIGS. 7a-d are views of an exemplary RFID-based identification andauthentication system according to some embodiments of the presentdisclosure.

FIGS. 8a-b is a schematic diagram of an exemplary barcode system toperform identification and authentication operations for an insulindispensing device according to some embodiments of the presentdisclosure.

FIGS. 9a-b illustrate views of an exemplary FLASH memory identificationand authentication system according to some embodiments of the presentdisclosure.

FIG. 10 is perspective view of an exemplary embodiment of a motherboardof the reusable part of a dispensing patch unit that includes anRFID-based identification and authentication system according to someembodiments of the present disclosure.

FIGS. 11a-b are views of exemplary embodiments of a dispensing patchunit that includes an RFID-based identification and authenticationsystem according to some embodiments of the present disclosure.

FIG. 12 is a view of an exemplary embodiment of a cradle unit providedwith an identification tag according to some embodiments of the presentdisclosure.

DETAILED DESCRIPTION

Embodiments disclosed herein are directed to insulin dispensing devicesand systems, which may include a dispensing unit to dispense insulin,and a validation (i.e. authentication) mechanism to enable operation ofthe dispensing unit based, at least in part, on a determination ofwhether operation of the dispensing, device is authorized. In someembodiments, the validation mechanism comprises an identifier coupled tothe first module of the dispensing unit to indicate identificationinformation associated with the first module, and an identificationreceiver coupled to the second module of the dispensing unit to receivethe identification information associated with the first module.

FIGS. 1a-b are schematic diagrams of a dispensing system that includes aremote control unit 1008 and a dispensing patch unit 10. FIG. 1a depictsa two part dispensing patch unit 10 comprising a disposable part (DP)200 and a reusable part (RP) 100. FIG. 1b depicts dispensing patch unit10 assembled from DP 100 and RP 200 attached together

In some embodiments, the DP comprises an identification marker (e.g.RFID tag), 222, and the RP comprises an identification reader 111.Operation of dispensing unit is authorized, for example, if theidentification reader 111 identifies the identification tag 222.

Referring to FIG. 2, an exemplary embodiment of a system 1000 fordispensing therapeutic fluid (e.g. insulin) into a body of a patient(which is typically the user of the system). The system includes aninfusion device configured as a two-part patch unit 10. The patch unit10 is securable to a skin adherable cradle unit 20. The system alsocomprises a remote control unit 1008 which communicates with thedispensing patch unit 10, enabling programming, user inputs and dataacquisition. In some embodiments, the remote control unit may comprise aPDA, watch, laptop, PC, iPod, iPhone or any other remote controlleddevice.

In some embodiments, the fluid delivery device/system can furthercomprise a sensing apparatus to monitor bodily analyte(s) e.g.,monitoring of concentration levels of glucose in the interstitial fluid(“ISF”). The sensing apparatus may comprise sensors, probes, electrodes,sensing elements, dedicated processing elements, delivery modules andcomponents, etc. Sensing of the analyte(s) can be performed within thebody (“in vivo”) or outside the body, and may be performed by varioustechniques such as optical techniques, electrochemical techniques, etc.The sensing apparatus can measure analyte concentration at measurementrates (or frequencies) that are either continuous, semi-continuous,periodic or discrete. Such a sensing apparatus is described in detail inco-pending/co-owned U.S. patent application Ser. Nos. 11/706,606 and11/963,481, and in co-pending/co-owned International Patent ApplicationNo. PCT/IL2008/001521, the contents of which are hereby incorporated byreference in their entireties. Components of the sensing apparatus canfurther include identification readers and markers.

In some embodiments, a dispensing apparatus and sensing apparatus(constituting a “system”) is configured to operate in one or more of aclosed loop, an open loop, or a semi-open loop mode.

The system 1000 may comprise a removable cannula 6 to penetrate theuser's skin 5. The patch unit 10 may be attached to a cradle unit 20that may be structured, for example, as substantially flat sheet (orplate) adherable to the user's skin 5. The use of the cradle unitenables connection/disconnection of the patch unit 10 to and from thebody. Embodiments of such system are described for example in aco-pending/co-owned U.S. publication no. 2007-0106218 and 2008-0215035,the disclosures of which are herein incorporated by reference in theirentireties.

An insertion device (also referred to as “inserter”) can be applied forinserting the cannula 6 into the user's body. An example for suchinsertion device is described in a co-pending/co-owned U.S. publicationno. 2008-0319414, the contents of which is hereby incorporated byreference.

Manual inputs can be provided by one or more buttons 1011 located at thedispensing patch unit 10. The components of the dispensing patch unit 10can be accommodated in one housing or in two housings or more. If thecomponents are accommodated in two housings, one of the housings cangenerally host complex/expensive components in the reusable part (RP)100 and the other housing can host simpler/inexpensive components in thedisposable part (DP) 200.

In accordance with some embodiments, the DP includes an identificationtag (also referred to as “ID tag”) 222, and the RP includes anidentification reader (also referred to as “ID reader”) 111.Furthermore, in some embodiments, a remote control unit for thedispensing device may include an identification reader.

In some embodiments, the functions carried out: by the patch unit may bebased on information received from the identification tag 222 via theidentification reader. For example, the received information may beprocessed to authenticate (e.g. validate) the disposable part. Theprocessing may include, for example, demodulating the receivedinformation and comparing at least some of the demodulated informationwith other data stored in the dispensing system. Thus, for example, theinformation received from the identification tag can comprise one ormore of an expiration date, a batch number, a serial number, amanufacturer, therapeutic fluid compatibility (e.g. whether it iscompatible with a specific brand of therapeutic fluid/insulin), alifetime period, a volume of the part, and the like.

Accordingly, pursuant to some embodiments, based on the identificationreading and processing the dispensing unit 10 may change itsfunctionality. For example, when the expiration date of the part haspast, the therapeutic fluid delivery will be limited, or completelystopped.

In some embodiments, the cradle unit 20 can comprise its ownidentification tag 333. For example, after connection of the assembledtwo parts of the patch unit with cradle unit, the patch unit's statuscan change and/or enable the delivery of therapeutic fluid, when theinformation stored on the identification tag 333 is read and identifiedby the identification reader 111 of the RP and subsequently authorized.

Identifying the identification tag 333 can be done periodically and/oras part of other procedures (e.g. before therapeutic fluid delivery,upon connection of the patch unit to the cradle unit). Thus, the statusof the patch unit 10 can be changed when there is no identificationand/or authorization, in case that the patch unit 10 is disconnectedfrom the cradle unit 20, e.g. pausing the delivery of therapeutic fluid.

In some embodiments, the cradle unit 20 and the DP 200 may compriseidentification tags, 333 and 222 respectively, and the RP 100 maycomprise an identification reader 111 to identify and authorizes both IDtags 333 and 222.

In some embodiments, the insertion device includes an identificationreader. According to these embodiments, the insertion of a cannula isenabled when the identification tag is authenticated by theidentification reader located in the insertion device.Additionally/alternatively the identification tag can be located on thecannula cartridge. In further embodiments, the cannula may be a part ofa cannula cartridge unit (which can also include a penetrating member,cannula hub and a septum), and/or an infusion set.

In some embodiments the remote control unit 1008 includes anidentification reader. Additionally, the remote control unit 1008 maycommunicate with RP 100, according to the identification reading. Forexample, the remote control unit 1008 can transfer the identificationreading to RP 100. Alternatively, the remote control unit may transferthe authentication and/or the identification status (e.g. if the readingare within acceptable range).

In some embodiments pairing the remote control unit to the RP and/ortransferring the key required for the pairing procedure, can be done byreading an identification tag.

FIG. 3 shows schematically various components of the dispensing patchunit 10 that are disposed within the reusable part 100 and thedisposable part 200 according to some embodiments.

In some embodiments, the disposable part 200 may include anidentification tag 222, as well as a power supply 240, a reservoir 220,delivery tube 230, and outlet port 210. The reusable part 100 mayinclude an identification reader 111, as well as electronics 130, atleast a portion of a driving mechanism 180, and operationbuttons/switches 15. According to such embodiments, power for activatingthe identification reader 111 located in the RP may be provided frompower supply (e.g. battery) 240 located in the DP. Electrical connectionbetween the two parts (RP and DP) can be established for example by aconnector 242, which are shared between the two parts. Thus, reading anidentification means (e.g. identification tag 222) can be enabled whenthe dispensing patch unit 10 is assembled. In some such embodiments, itis preferred to read the identification tag of a new DP, beforereplacing the older disposable part 200, while it is still connected tothe reusable part 100. Alternative embodiments may include an additionalpower supply (which may be located in the RP for example) electricallyconnected to the identification reader 111, enabling identification whenno disposable part 200 is connected.

The patient can operate the dispensing unit 10 either by a remotecontrol unit 1008 (as shown in FIG. 2) or by one or morebuttons/switches 15 located on the dispensing unit 10. In someembodiments, operation based on the buttons 15 may be directed for bolusdose delivery.

In some embodiments, the driving mechanism can be constituted bycomponents disposed in both parts (DP and RP). In some embodiments, thepower supply may be included in the reusable part, or shared betweenboth parts (DP and RP).

Because the ID reader is generally more expensive than the ID tag, andbecause the RP will generally house the relatively expensive componentsof the patch unit, in some embodiments, the identification tag 222 maybe located in the DP while the identification reader 111 may be locatedat the RP. However, alternatively, the ID tag may be located at the RPand the identification reader may be located at the DP.

FIG. 4a shows an exemplary embodiment of a fluid dispensingdevice/system 1000 for dispensing a therapeutic fluid to a patient. Thesystem 1000 includes a fluid dispensing patch unit 10, a remote controlunit 1008, and a cradle unit 20. The dispensing patch unit 10 includes areusable part 100 and a disposable part 200. The reusable part 100 isconfigured to be detachably connected to the disposable part 200. Thesystem functionality (e.g. status, mode of operation), may be based atleast in part on identification and authentication of the assembledparts comprising the dispensing patch unit. The functions that may beaffected according to the identification and/or authentication typicallyincludes dispensing therapeutic fluids, programming the system (e.g.setting the amount of fluid to be delivered), activation of thedispensing unit (i.e. making it operable) and/or deactivation of thedispensing unit. The identification and/or authentication may beperformed upon the attachment of the two parts via an ID tag 222 locatedat the disposable part and via an ID reader 111 located at the reusablepart. The assembled patch unit may be connected and disconnected fromthe cradle unit 20 upon user discretion and, in some embodiments, theassembled patch unit functionality (e.g. pause/suspend/resume thedispensing of the therapeutic fluid) may be changed according to the IDreading. The ID reading performed by the ID reader (e.g. ID reader 111located at the reusable part 100), can generate a signal (or a set ofsignals) based on the ID tags being read (e.g. ID tag 333 located at thecradle unit 20).

In some embodiments, the assembled patch unit functions are determinedbased on the identification and/or authentication of an ID tag. It ispreferred in such embodiments, to enable wireless communication (e.g. RFcommunication, IR communication) and programming of the assembled patchunit, regardless of the ID tag reading, while the dispensing of atherapeutic fluid to a patient is based upon the ID tag reading. Forexample, the assembled patch unit can dispense bolus amounts oftherapeutic fluid after ID tag reading, while full functionality of theassembled patch unit (e.g. bolus and basal delivery) is enable afterauthentication of the ID tag. These modes of operation enable the usageof the device in emergencies, but prevent the full usage withoutauthentication. Furthermore, some embodiments enable only manual bolusdelivery (i.e. bolus programmed using buttons located on the patchunit), without an authentication.

FIG. 4a illustrates an exemplary disposable part 200 having a reservoir220 and a piston 113 forcibly displaceable along the reservoir. Thepiston 113 is connected to a threaded piston rod 112 having a tip 289with teeth. The piston rod 112 may be manually gripped at the tip 289 toenable manual linear displacement of the piston 113 along the reservoir220. An engagement member 2861 may be provided, located within a chassis281. By virtue of such an engagement member, the piston may be displacedalong the reservoir according to one of the two modes: a first modeenabling free displacement of the piston rod, and a second mode enablinga controlled displacement of the piston rod.

The disposable part 200 includes an outlet port 210 having a connectinglumen (not shown in FIG. 4a ). The connecting lumen is fluidly coupledto the reservoir 220 through a connecting tube 230 and fluid channel232. The connecting tube 230 can be supported by and deployed on achassis (indicated by dotted lines in FIG. 4a ). The disposable part 200further includes a power supply 240 (e.g. a battery) which supplieselectrical energy to at least one of the reusable part 100 and/or thedisposable part 200 when the two parts have been assembled (asillustrated in FIG. 4a ).

The reusable part 100 includes at least a portion of a driving mechanismhaving a motor 184 and gears 182 to drive a threaded cylinderreferred-to as a “sleeve” 186. In some embodiments, the motor 184 cancomprise a Stepper motor, DC motor, SMA actuator or the like. Thereusable part 100 can further comprise at least a portion of anocclusion sensor 140 with a sensor 142 which electrically connected tothe PCB/electronics 130. The occlusion sensor 140 is configured tomonitor the fluid condition in its delivery path, e.g. in the connectingtube 230 and/or connecting lumen and/or cannula. Such an occlusion mayprevent delivery of therapeutic fluid to the patient's body. Theocclusion sensor 140 may thus alert/notify the user (e.g. by displayingan alert on a screen (located on the dispensing unit 10 and/or on theremote control unit 1008, and/or any other notification mechanisms ormodules, such as buzzer or vibrator) that a partial or completeocclusion has occurred and that it is time to replace the disposablepart 200. Based on signals provided by the occlusion sensor 140,operation of the dispensing unit 10 may be halted/suspended.

The sleeve 186 is configured to receive the piston rod 112 of thedisposable part 200 upon assembly/connection of the two parts (100 and200), and to transfer rotational moment/force to the tip 289 and thepiston rod 112. The reusable part 100 further includes electronicsdesignated by the common numeral 130. The electronics may comprise acontroller, a processor, a transceiver, an antenna etc.

In some embodiments, in which the power supply 240 is located in thedisposable part 200, the reusable part 100 may include dedicatedconnectors to establish electrical communication between the powersupply 240 (e.g. a battery) and electronics 130.

Referring to FIG. 4b , a perspective view of an exemplary embodiment ofthe connection of the dispensing patch unit 10 to the cradle unit 20 isshown.

An ID tag 333 located on the base 37 of the cradle unit 20, can beidentified by an ID reader 111 located at the reusable part 100, and theassembled patch unit 10 becomes operable only upon identification andauthentication which have been performed during/after patch unit 10connection to the cradle unit 20. The cradle unit may also comprise awell 30 through which the cannula 6 can be inserted to the subcutaneoustissue.

The fluid dispensing device partially described above is disclosed inour co-owned/co-pending International Patent Application No.PCT/IL09/000,388, the content of which is hereby incorporated byreference in its entirety.

The above-mentioned identification tags 222, 333 located at the DP andat the cradle unit can be one or more of, for example, an RFIDtransponder, a barcode, and/or a FLASH memory, rewriteable memory andthe like.

According to some embodiments, the identification information stored inthe ID tags 222, 333 is received and/or read by the ID reader 111provided at the RP. Subsequently, a determination is made whether theidentification information corresponds to pre-defined data stored (e.g.in a memory), for example, on the RP part. The identificationinformation is preferably sufficient to enable unequivocalidentification and authentication of the parts. This information mayinclude, for example, at least one of a manufacturing date and a batchnumber, such that upon completing the identification/authentication,imitation of DPs, and intentional or inadvertent use of DPs would beprevented.

Additional information such as amount, type and concentration of insulinin the reservoir of the DP, expiration date, patient personalinformation such as name, and prescription requirements may also beincluded in the information stored by the DP identification tag.

The ID reader may be located proximally to the ID tags when the RP andDP are connected and the patch unit is connected to the cradle unit.

Alternatively, the ID tags and ID reader can be located anywhere on theRP, DP, and cradle unit and wireless communication between the ID tagsand ID reader may be implemented to enable identification of the ID tagsby the ID reader located relatively remote from one another.

The identification reader 111, configured to read the information storedin the ID tag 222 located at the DP, may be, for example, an RFIDantenna, a barcode scanner, and/or a FLASH memory reader.

In some embodiments, the process of identification and authentication ofthe parts may be mechanical instead of electrical. Under thesecircumstances, the validation mechanism would be such that it would bemechanically feasible or not feasible to connect the RP, the DP, and/orthe cradle unit. Thus, operation of the dispensing device would beenabled if the parts can be mechanically connected to each other. Forexample, a “lock” and a “key” may be provided at the respective parts ofthe device and the device would operate, under these circumstance, ifthe key of one part mechanically fits (e.g., in a mating configuration)in the lock of another part of the device.

In some embodiments, the process of parts identification and/orauthentication may be both electrical and mechanical. For example, ifthe information stored in the identification tag 222 is not identifiedand/or authenticated by the identification reader 111, then a physicalconfigurational change may mechanically prevent parts assembly or deviceperformance, thus rendering the device inoperable (i.e. unable todispense therapeutic fluid). For example, one such physicalconfigurational change may be the intentional occlusion of the tubethrough which insulin is dispensed.

In some embodiments, the data received by the ID reader is transferredto a processor-based device (not shown), included in the electronics130, that can compare the information stored in the identification tag,and read by the identification reader, with a dedicated validation datastored within a database provided in a storage device (e.g. non volatilememory) which is in communication with the processor. For example, thevalidation data may include acceptable/pre-defined expiry datesaccording to manufactured batches. If a DP with an unacceptable expirydate is assembled, the expiry date will be compared with the acceptableexpiry dates stored in the validation data and device operation willthus be restricted.

In such embodiments, the dispensing unit 10 would become operationalafter the identification reader 111 identifies the identification tag222 and the information read by the reader 111 has been validated by theprocessor.

In some embodiments, the validation data may be updated, as described indetail in FIG. 5. FIG. 5 shows a flow chart of an exemplary embodimentof identification procedure 500. The procedure is typically performedupon components (e.g. cannula, cradle, reservoir, etc.) replacement(e.g. when replacing a reservoir), periodically, and when otheroperation of the system/device are effected (e.g. verifying cradleidentification before delivering therapeutic fluid). The informationstored in the identification marker (e.g. ID Marker) is read by theidentification reader, at step 51. The read information validity isevaluated, at step 53, preferably by processing it and comparing it todata stored in a validation database.

If the read data is valid, a notification is provided to the user, shownin step 56. The notification typically includes a conformation about thevalidation process and data related to the identification marker. Thevalidation results in status change 57 (e.g. changing mode of operation)of the system, to enable/disable function(s) of the system. For example,an inserter may become operable (e.g. enabling the insertion of acannula) after validating an ID marker located on a cradle. Additionallyand/or alternatively the connection between components may be enabled61, enabling part replacement.

If the read data is not valid, a notification is provided 55 to theuser. The notification typically acknowledges the user about thefalse/invalid/non-valid reading/information. Then, further reading(s)may be carried out repeatedly (designated as for example by a dottedarrow) or the system operation 59 can be changed upon invalidation. Forexample, the therapeutic fluid delivery is stopped when the data readfrom an identification marker located on a cradle is not valid.

It should be noted that in some embodiments some steps may be omitted,such as a notification may not be provided upon invalidation (i.e.omitting step 55), the sequence of steps may be different (e.g. step 57before step 56), and/or the procedure may include additional steps.

In some embodiments, the database can be updated to comply with theidentification tags of different DPs and/or cradle units. For example,if the insulin concentration of the insulin retained in the reservoirhas been modified and the insulin concentration is a parameter stored inthe ID tag and requires compliance with a validation database, then thevalidation database can be updated in accordance with the user's insulinconcentration requirements. Without update of the validation database,operation of a DP with the various insulin concentrations may not bepossible/limited.

According to one such embodiment, the validation database may beaccessible for update only by authorized personnel (e.g. physicians,nurses, CDEs, caregivers, parents of diabetic child) using, for examplea certain code/password. Update of the validation database can beperformed for example via the remote control (RC) that is incommunication with the processor using a logon code or via a PC incommunication with the processor using a logon code.

If upon a validation procedure the information stored in theidentification tag 222 does not match the data of the validationdatabase (e.g. expiry date has elapsed), the processor will not enableoperation of the dispensing device. Otherwise, the dispensing devicewould be operable.

Referring to FIG. 6, a schematic diagram of an RFID-based patch unit 10to perform identification and/or authentication procedures with respectto its different parts is shown. The RFID-based system comprises anidentification tag 222 (RF tag) and a tag antenna 221 that communicateswith an identification reader 111 (RF reader) and reader antenna 121 bytransmitting, for example, RF signals.

In some embodiments, a carrier signal is generated by the reader 111(optionally, based on a request from the host computer or processor130′) and sent out (transmitted) throughout the reader antenna 121 tothe tag 222 and tag antenna 221. The tag 222 receives the carrier signaland sends/transmits back a modulated signal. The reader antenna 121receives the modulated signal and sends it to the reader 111. The readerthen decodes the data brought by the signal and transfers the results tothe processor 130′. In some embodiments, the carrier signal generated bythe reader 111 does not convey any information until the data from thetag 222 is added to the signal by modulation and then decoded on thereceiving end, i.e. the reader 111, by, for example, performingdemodulation operations.

The RFID tag 222 and tag antenna 221 may be located in the DP 200. Thereader 111 and reader antenna 121 may be located in the RP 100, whichfurther contains processor 130′. In some embodiments the power supply240 may reside in the DP 200 of the patch unit 10.

RFID tags are generally available in three varieties: passive, active,or semi-passive. Passive tags require no internal power source, thusbeing pure passive devices (they are only active when a reader is nearbyto energize them). When an electrical current induced in the antenna byan RF signal, a power is provided to an integrated circuit of the ID tagto power it up and thereafter to transmit a response. Passive tags cangenerally be read by readers located at a relatively short distance.

Active tags require a dedicated power source, usually a small battery,which is used to power the integrated circuits and broadcast the signalto the reader. Active tags are typically much more reliable than passivetags due to the ability of the active tags to interact with a reader(e.g., conduct a “session”). Active tags, due to their onboard powersupply, also transmit at higher power levels than passive tags, thusenabling them to be more effective in “RF challenged” environments (i.e.when the Signal-to-Noise (S/N) ratio is low), or at longer distances.Some active RFID tags include sensors such as temperature gauges whichcan be used for example to monitor the temperature of the patch unit. Onthe other hand, active tags are generally larger in size and moreexpensive to manufacture, and their potential shelf life is typicallyshorter.

Semi-passive tags are similar to active tags in that they have their ownpower source (e.g., a battery), but they typically do not broadcastcommunication signals. The RF energy is reflected back to the reader asdone by a passive tag. Semi-passive tags have higher sensitivity thanpassive tags, and longer battery life than active tags.

In some embodiments, the RFID tag may be a passive tag. Use of a passivetag enables tag miniaturization and low cost, and is applicable becausethe limited read range of the passive tag is not a factor in the currentapplication, due to the small dimensions of the patch unit.

In some embodiments, the RFID tag can be an active tag or semi-passivetag, i.e. it would have its own power source. Such embodiments arefeasible because the power supply of the patch unit is preferablylocated in the DP, and can thus provide the necessary power for theactive or semi-passive RFID tag.

In some embodiments, the RFID tag status changes from passive to activeor semi-passive, according to the connection condition of the two partstogether. For example, an RFID tag located on a cradle is passive untilit is connected to a dispensing unit. The passive RFID tag enables thedetermination of the connection condition between the cradle and thedispensing unit. Thus, drug/fluid delivery is halted when there is noconnection and it is resumed when there is a connection. The activestatus of the RFID tag enables its reading by another unit (e.g. aremote control unit), not connected to it.

In some embodiments, the system can include a disabling mechanism toharm or ruin the RFID tag, making it unreadable during the assembly ofthe patch unit (i.e. when the RP is being connected to the DP).Rendering the RFID tag unreadable can be done by configuring the RPhousing to be pushed against the RFID tag, thus directly damaging itsfunctionality. Alternatively, the RFID tag can be subjected to overload(e.g. relatively high level of electrical power), which may be inducedby the RFID reader, and thus melting electrical connectors. Damaging theRFID tag to disable additional readings prevents reusing or undesirableuse of a single use part.

Referring to FIGS. 7a-d , views of exemplary a two-part patch unit witha remote control unit and an RFID-based validation mechanism (e.g.,identification and/or authentication system) are shown. FIGS. 7a and 7cdepict the disassembled and assembled patch unit, respectively. An RFidentification reader 111 is located at the RP 100 and communicates viaRF communication with an identification tag 222 located at the DP 200.The identification and authentication approval or rejection can bedisplayed as a message on a remote control unit's 1008 display (asshown, for example, in FIGS. 7b, 7d ), or generated as an audio signaland/or an audio/visual signal, and/or vibrational notification and/oralerting the patient in any other way.

In some embodiments, notification of identification and authenticationapproval or rejection can be generated directly by the patch unit, forexample, by the RP, as an audio signal (e.g., via a buzzer) and/or byvibration and/or as a visual signal displayed on a screen located on theRP, and/or by alerting the patient in any other way.

Referring to FIGS. 8a-b , a schematic diagram of an exemplary two-partpatch unit with a bar code-based validation mechanism to performidentification and authentication operations with respect to itsdifferent parts is shown according to some embodiments.

In such embodiments, the identification tag is configured as a bar code555 representative of identification information, and which includes aseries of parallel, adjacent bars 555 b and spaces 555 a, as shown inFIG. 8 b.

A barcode reader 666 is provided and can decode a bar code by directing,for example, a light source 666 a towards the bar code, emitting light(or other form of energy such as IR radiation) and measuring theintensity of light reflected back by the bar code. The pattern ofreflected light is detected by a detector 666 b (e.g. a photodiode)which produces an electronic signal that corresponds to the detectedpattern. This signal is then decoded to retrieve the original data whichis then transmitted to the processor 130′. The energy required to powerthe barcode reader can be provided by a power supply 240.

In some embodiments, the bar code 555 may be located at the DP 200and/or at the cradle unit. The bar code reader 666 may be located at theRP 100, as well as the processor 130′. The power supply 240 may residein the DP 200 of the patch unit 10. Alternatively, the power source 240is located in RP 100 and may be rechargeable.

In some embodiments, the bar code 555 can be harmed or ruined, making itunreadable during the assembly of the patch unit (i.e. when the RP isbeing connected to the DP). Rendering the bar code unreadable can bedone by configuring the RP housing to rub against the bar code.Alternatively, the barcode can be removed by the user. Damaging the barcode to disable additional readings prevents reusing or undesirable useof a single use part.

It should be noted that although the embodiments described refer to abar code located on a DP, the bar code can be placed on any part of thesystem. Furthermore, the barcode reader may be located on other parts ofthe system (e.g. insertion device, remote control unit). In someembodiments, the system can include more than one component having abarcode and/or barcode reader.

Referring to FIGS. 9a-b , views of an exemplary two-part patch unit witha FLASH memory-based validation mechanism to perform identification andauthentication are shown according to some embodiments. The FLASH-basedvalidation system includes a FLASH memory provided at the disposablepart 200, which serves as an identification tag 222, and a FLASH readerprovided at the RP 100, serving as an identification reader 111. In someembodiments, the FLASH reader is integrated with the dispensing unitprocessor.

FIG. 9a depicts the disassembled patch unit. The identification reader111 comprises connectors 110 which, upon connection of the RP to DP(shown in FIG. 9b ), contact the corresponding connectors 110′ of theidentification tag 222 provided at the DP. Once the parts (RP and DP)are physically connected, the identification and/or authenticationprocedure can be performed.

In some embodiments, a cradle unit (not shown) may also include a FLASHmemory identification tag and connectors that contact the correspondingconnectors of the identification reader provided at the RP, for example.

The FLASH memory may be any known FLASH chip (commercially available, orotherwise).

In some embodiments, the data stored on the FLASH memory is altered asresult of the connection/usage of the part. This enables the tracking ofthe part's period of usage, the number of connections anddisconnections, and thus may prevent reuse or undesirable use of singleuse parts (e.g. a reservoir, a cannula, a DP, a cradle).

Referring to FIG. 10, a perspective view of an exemplary embodiment of aPrinted Circuit Board (PCB) 101 of the reusable part 100, including therelevant components of an RFID-based validation mechanism to performidentification and authentication is shown. The PCB 101 comprises anRFID reader 111, an RFID reader antenna 121, and a processor 130′. TheRFID reader 111 is configured to generate a carrier signal transmittedby antenna 121 to an RFID tag and tag antenna possibly located on otherparts of the device, e.g., DP, cradle unit (shown for example in FIG.11a ). A tag modulated signal is subsequently received by the readerantenna 121, forwarded to the RFID reader 111 which can decode thesignal and transfer the encoded information/data to the processor 130′.

Referring to FIGS. 11a-b , views of exemplary embodiments of thedisposable part 200 of a dispensing patch unit with the relevantcomponents of a RFID-based validation mechanism to performidentification and authentication are shown.

As illustrated in FIG. 11a , the RFID tag 222 (also referred-to as “DPTag”) and RFID tag antenna 221 are located on the inner side of thedisposable part housing 202. Both the RFID tag 222 and the antenna 221are positioned adjacent to the reservoir 220 such that there is nointerference with the piston and/or fluid delivery when the disposablepart and reusable part are connected.

As illustrated in FIG. 11b , the RFID tag 222 and RFID tag antenna 221are located on the disposable part chassis 204. The chassis 204 mayhouse some of the disposable components such as power supply 240,delivery tube 230 and outlet port 210. The tag 222 and antenna 221 ofthe DP chassis 204 are positioned so that they are aligned with the RFIDreader 111 and antenna 121 of the reusable part 100 to facilitatecommunication between the components of the RFID-based mechanism.

Referring to FIG. 12, a view of an exemplary embodiment of the cradleunit 20 is shown. The cradle unit 20 includes an identification tag 333,a well 30 through which the cannula can be inserted, a base 37, a border39, and locking mechanisms, which may comprise latches 22, 24 to securethe dispensing unit. In some embodiments, the cradle may include thereservoir and/or the power supply. When the dispensing unit 10 isconnected with the cradle 20, the identification tag 333 is identifiedby an identification reader located at the dispensing unit and thusauthentication of the patch unit 10 and cradle unit 20 is possible. Asshown, in some embodiments, the tag 333 is positioned in the left cornerof the section where the reusable part is supposed to be placed whenconnecting the dispensing unit 10, so that the identification reader ispositioned opposite to the tag 333 enabling uninterrupted communicationand identification. In some embodiments, the reader can be positioned inthe section where the DP is placed when connected to the cradle.

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made to the disclosedembodiments, as well as to the individual features thereof, withoutdeparting from the spirit and scope of the present disclosure. Forexample, the locations of the ID marker and the ID reader each may belocated on any portion of the system. In some embodiments, the ID markermay be located on a single use component such as, cannula, cradle,reservoir, tubing, vial for therapeutic fluid, DP, including theirpackages, covers and the like. In some embodiments, the ID reader may belocated on reusable components (i.e. components configured for more thana single usage) and/or component having a prolong lifetime (e.g. months,years), such as remote control unit, dispensing unit, insulin pump, RPand inserter.

The processors described herein may include a controller, a CPU, a MCU,a memory device and/or plurality of such components. The processordevice(s) may further include peripheral devices to enable input/outputfunctionality. Alternatively and/or additionally, in some embodiments,special purpose logic circuitry, e.g., an FPGA (field programmable gatearray) or an ASIC (application-specific integrated circuit) may be usedin the implementation of the processor device(s).

Various embodiments of the subject matter described herein may berealized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof.These various embodiments may include embodiment in one or more computerprograms that are executable and/or interpretable on a programmablesystem including at least one programmable processor, which may bespecial or general purpose, coupled to receive data and instructionsfrom, and to transmit data and instructions to, a storage system, atleast one input device, and at least one output device. In particular,some embodiments include specific “modules” which may be implemented asdigital electronic circuitry, integrated circuitry, specially designedASICs (application specific integrated circuits), computer hardware,firmware, software, and/or combinations thereof.

These computer programs (also known as programs, algorithms, procedures,processes, software, software applications or code) include machineinstructions for a programmable processor, and may be implemented in ahigh-level procedural and/or object-oriented programming language,and/or in assembly/machine language. As used herein, the term“machine-readable medium” refers to any computer program product,apparatus and/or device (e.g., magnetic discs, optical disks, memory,Programmable Logic Devices (PLDs)) used to provide machine instructionsand/or data to a programmable processor, including a machine-readablemedium that receives machine instructions as a machine-readable signal.The term “machine-readable signal” refers to any signal used to providemachine instructions and/or data to a programmable processor.

To provide for interaction with a user, the subject matter describedherein may be implemented on a computer having a display device (e.g., aCRT (cathode ray tube) or LCD (liquid crystal display) monitor) fordisplaying information to the user and a keyboard and a pointing device(e.g., a mouse or a trackball) by which the user may provide input tothe computer. Other kinds of devices may be used to provide forinteraction with a user as well; for example, feedback provided to theuser may be any form of sensory feedback (e.g., visual feedback,auditory feedback, or tactile feedback); and input from the user may bereceived in any form, including acoustic, speech, or tactile input.

Some or all of the subject matter described herein may be implemented ina computing system that includes a back-end component (e.g., as a dataserver), or that includes a middleware component (e.g., an applicationserver), or that includes a front-end component (e.g., a client computerhaving a graphical user interface or a Web browser through which a usermay interact with an embodiment of the subject matter described herein),or any combination of such back-end, middleware, or front-endcomponents. The components of the system may be interconnected by anyform or medium of digital data communication (e.g., a communicationnetwork). Examples of communication networks include a local areanetwork (“LAN”), a wide area network (“WAN”), and the Internet.

The computing system may include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other.

Some embodiments of the present disclosure preferably implement theidentification and/or authentication via software operated on aprocessor contained in a remote control device of an insulin dispensingsystem and/or a processor contained in a insulin dispensing device beingparty of an insulin dispensing system.

Any and all references to publications or other documents, including butnot limited to, patents, patent applications, articles, webpages, books,etc., presented in the present application, are herein incorporated byreference in their entirety.

Although a few variations have been described in detail above, othermodifications are possible. For example, the logic flow depicted in theaccompanying figures and described herein do not require the particularorder shown, or sequential order, to achieve desirable results. Otherembodiments are possible, some of which, are within the scope of thefollowing claims.

What is claimed is:
 1. A system for dispensing a therapeutic fluid to abody of a user, the system comprising: a reservoir to contain thetherapeutic fluid; a cannula insertable into the body of the user,providing a fluid path between the reservoir and the user's body; adriving mechanism configured to engage with the reservoir to dispensethe therapeutic fluid; a processor controlling the driving mechanism; afirst ID marker for authenticating at least a portion of the system; anID reader for reading the first ID marker and for providing a signal tothe processor; and a power source to provide power to at least one ofthe driving mechanism and the processor, wherein the processor enablesone or more functions of the system based on the signal received fromthe ID reader, and wherein the system includes a dispensing unit whichincludes the reservoir, the driving mechanism and the first ID marker,wherein the system includes a remote control unit which includes the IDreader, wherein both the remote control unit and the dispensing unitidentify communications between each other with a specific key, whereinthe specific key is shared and set by the units via a second ID markerbeing read by the ID reader of the remote control unit to pair the unitsand once paired the remote control unit and the dispensing unitcommunicate only with each other and no other unit.
 2. The system ofclaim 1, further comprising a sensor for monitoring analyte levels. 3.The system of claim 1, wherein the dispensing unit comprises at leasttwo portions, a first portion having the first ID marker and a secondportion having another ID reader.
 4. The system of claim 3, wherein thefirst portion interacts with the second portion.
 5. The system of claim1, wherein the ID reader includes an RFID reader and the first ID markerincludes an RFID tag.
 6. The system of claim 1, wherein the first IDmarker includes a rewriteable memory.
 7. The system of claim 1, whereinthe first ID marker includes a barcode and the ID reader includes abarcode reader.
 8. The system of claim 1, further comprising a databasestoring information related to reading of the first ID marker, at leasta portion of the signal received from the ID reader comprisesinformation, and the processor compares at least some of the informationreceived from the ID reader with at least some of the information storedin the database.
 9. The system of claim 1, further comprising adisabling mechanism to disable subsequent reading of the first ID markerafter a connection between at least one first portion of the system withat least one second portion of the system.
 10. The system of claim 9,wherein the disabling mechanism subjects the first ID marker to anoverload of electrical power.
 11. The system of claim 10, wherein thedisabling mechanism is induced by the ID reader.
 12. The system of claim1, wherein the first ID marker is a bar code.